Statistical Techniques for Process Validation Made Easy – Part 2


Click here for Part 1 »
Note. It is not a requirement to attend both PV webinars.

Course description

Process Validation is defined as: “Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” Establishing objective evidence can seem like a daunting task. A Global Harmonization Task Force (GHTF) was established to create a guidance document to help establish best practices for industry – especially the application of valid statistical techniques.

The goal of these two webinars is demonstrate how valid statistical techniques contribute to Process Validation efforts. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the GHTF. The application of valid statistical techniques is encouraged by the US FDA’s Quality System Regulation, the FDA’s Current Good Manufacturing Processes (cGMP), and ISO Standard 13485. Emphasis will be placed on best practices for quality systems in industry.

These fast-paced webinars will cover the details of application without the burden of statistical complexity. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

While most webinars cover the “What and Why” for a subject, these webinars will also give ideas on the “How To” for valid statistical techniques. This “How To” will cover actual examples of application and discuss methods for writing protocols and reports. The discussion of documentation is especially important for FDA-regulated companies.

You will hear directly from an industry expert on this important topic and you can ask questions and get answers. The presenter has over 20 years of experience helping a broad variety of firms apply statistical tools and techniques.

Program overview

  • Explore valid statistical techniques for Process Validation
  • Provide a mapping of tools and techniques to IQ, OQ and PQ activities
  • Provide examples of industry best practices in each area
  • Discuss options for documentation
  • Demonstrate how these tools support regulatory compliance, especially if mandatory or voluntary action is required

Program-at-a-glance – Part 2

  • Applying Design of Experiments for OQ
  • Sampling Plans for PQ
  • Process Control Charts for PQ and Process Monitoring
  • Question and Answer Period

Who should attend

This material will appeal to quality professionals and managers in large and small companies.
Instruction is targeted to: quality engineers, process & manufacturing engineers, regulatory compliance professionals, and members of the leadership team.


There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our “keep-it-simple” approach.


IndustryMedical Device
LevelBasic, Intermediate

Peter L. Knepell